NCT03951987

Investigation How CG5503 is Taken up and Excreted From the Body After 2 Minutes Intravenous Infusion With and Without Oral Co-administration of Charcoal

Investigation of the Pharmacokinetic Properties of CG5503 After 2 Minutes Intravenous Infusion With and Without Oral Coadministration of Charcoal in a Randomised, Open, Single Dose, 2-way Crossover, Phase I Study in 12 Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This was a Phase I study in 12 healthy male participants to compare the pharmacokinetic properties of CG5503 (how it is taken up and excreted from the body) after 2 minutes intravenous (i.v.) infusion with and without oral co-administration of charcoal to investigate a potential gastrointestinal secretion of CG5503. During the course of the study each participant received two infusions of 40 mg CG5503 without (treatment A) and with (treatment B) oral co-administration of charcoal. In treatment B, eight doses of 5 grams charcoal powder were co-administered orally at defined time points. The wash out phases were to be at least 4 to 14 days between the treatment periods.

Conditions

• Pharmacokinetic

Interventions

Type	Name	Description
DRUG	4 ml CG5503	4 ml of the CG5503 infusion solution corresponding to 40 mg CG5503 (tapentadol hydrochloride).
DRUG	5 g charcoal powder	Oral administration of 5 g charcoal powder suspended in 100 ml tap water.

Timeline

• Start date: 2004-02-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2019-05-16
• Last updated: 2019-05-16

Locations

1 site across 1 country: Germany